btl-785f device for non-invasive lipolysis and circumference reduction of the abdomen

Conditions: Fat Burn

Summary: this study will evaluate the clinical safety and the performance of the btl-785f system equipped with btl-785-1 applicator for non-invasive lipolysis (breakdown of fat) of the abdomen and reduction in circumference of the abdomen. safety measures will include documentation of adverse events (ae) during and after the procedures. follow-ups visits at 1 month and 3 months after the final treatment will be held.


Eligibility criteria:
inclusion criteria: * healthy male or female subjects over 21 years of age seeking treatment for abdominal circumference reduction * subjects should be able understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the informed consent form * presence of clearly visible fat deposits in the abdominal area as deemed appropriate by the investigator (e.g. by pinch test or ultrasound fat thickness measurement) * subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring and/or weight loss during study participation. * no procedure for abdominal fat reduction (including cellulite treatment) in the last six months. * subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting a significant change of weight in either direction during study participation. * willingness to comply with study instructions and to return to the clinic for required visits. exclusion criteria: * bacterial or viral infection, acute inflammations * impaired immune system * isotretinoin use in the past 12 months * skin related autoimmune diseases * radiation therapy and/or chemotherapy * poor healing and unhealed wounds in the treatment area * metal implants * permanent implant in the treated area * pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body * current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles * history of any type of cancer * active collagen diseases * cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis and thrombosis) * pregnancy/nursing or ivf procedure * history of bleeding coagulopathies, use of anticoagulants * any active condition in the treatment area, such as sores, psoriasis, eczema, etc. * any surgical procedure in the treatment area within the last three months or before complete healing * poorly controlled endocrine disorders, such as diabetes * acute neuralgia and neuropathy * kidney or liver failure * sensitivity disorders in the treatment area * varicose veins, pronounced edemas * previous liposuction in the treatment area in the last six months * unstable weight within the last 6 months (change in weight ± 3%) * previous body contouring or cellulite treatments in the abdominal area in the last six months * any other disease or condition (e.g. hernia) at the investigator discretion that may pose risk to the patient or compromise the study

Keywords: lipolysis circumference reduction non-invasive